The Recall Desk
HighFDA (Devices)·Z-0565-2023·Announced 2022-12-21

DeRoyal Surgical Procedure Packs Recalled Due to Defective Steri Drapes

DeRoyal is recalling procedure packs containing recalled 3M Steri Drapes. Affected lot 56181816 (exp. 10/1/2023) distributed across multiple U.S. states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of surgical procedure packs that constitute risk-of-harm medical devices. While no illnesses or injuries are reported in the source, and the specific hazard affecting the included 3M Steri Drapes is not detailed, the recall reflects a serious enough defect that it required manufacturer action to withdraw the product.

Plain-English summary

DeRoyal Industries Inc is recalling 27 kits of the DeRoyal PEDI ORTHO PACK (Reference 89-5323.20) due to included 3M Health Care Steri Drapes that have been subject to recall by the component manufacturer.

The recalled procedure packs were distributed across multiple U.S. states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi. The affected lot number is Lot 56181816, with an expiration date of October 1, 2023.

Individuals and healthcare facilities that may have received this product should be aware of the recall and take appropriate action to identify any affected stock in their possession.

The recalled product

Product
DeRoyal PEDI ORTHO PACK, REF 89-5323.20
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Procedure Packs
Affected units
27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: Lot 56181816 exp 10/1/2023

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

Related recalls

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